Deep Sedation in Single‐Shot Pulmonary Vein Isolation: A Head‐to‐Head Look at Two Pulsed Field Versus Cryoballoon Ablation Approaches

ABSTRACT Background Deep sedation (DS) is routinely used during single‐shot pulmonary vein isolation (PVI) to optimize patient comfort and procedural stability. However, data on sedative requirements and procedural tolerance of pulsed field ablation (PFA) under DS compared with thermal technologies remain limited. Methods In this single‐center study, consecutive patients underwent PVI with cryoballoon (CB), PFA using a pentaspline catheter (PC) or the balloon‐in‐basket catheter (BC). All procedures were performed under DS with midazolam, fentanyl, and propofol, administered by electrophysiology staff without anaesthesiologist supervision. Propensity score matching (1:1:1) was applied for age, sex, body mass index, and hypertension. Procedural characteristics, sedative/analgesic requirements, and complications were analyzed. Results Acute PVI without major complications was achieved in all 156 enrolled patients. PC procedures were associated with higher body‐weight‐ and time‐adjusted requirements for propofol (CB: 0.10 ± 0.04 mg/kg/min; PC: 0.15 ± 0.04 mg/kg/min; BC: 0.11 ± 0.03 mg/kg/min; p < 0.001) despite the lowest total dose of propofol used (CB: 440 ± 144 mg; PC: 348± 80 mg; BC: 433 ± 160 mg; p = 0.00). Procedural times (CB: 47.5 [40–60] min, PC: 29 [25–35] min, BC: 47.5 [40–56] min, p < 0.001) and fluoroscopy times (CB: 9.5 [6.3–13.6] min; PC: 6.2 [4.4–9] min; BC: 7.2 [6.1–11.2] min, p = 0.001) were shortest in the PC group. Sedation‐related hemodynamic stability was comparable across all cohorts. Conclusions The novel BC demonstrated excellent feasibility under DS, with reduced normalized sedative requirements compared with the PC and a safety profile comparable to CB ablation. These findings suggest that optimized waveform design and field homogeneity may enable safe and comfortable PVI under DS without the need for general anesthesia.